Alcami recently contributed to an article in Specialty Chemicals Magazine titled "HPAPI's: A CDMO View."

Alcami has gained extensive knowledge on HPAPI manufacturing from building new suites at its US API development and manufacturing site

Over the course of 2016-2017, global CDMO Alcami built and qualified a new facility for highly potent compounds at its facility in Germantown, Wisconsin. During the design phase, says Adam Kujath, global senior director of manufacturing science & technology, the company put considerable thought into what was needed to match its existing capabilities – it has a very diverse customer base and works with many different molecules – to market needs.

Alcami is connecting with its customers faster with the launch of Alcami RightNow™, the company’s new convenient and responsive web-based live chat function.

The latest in the company’s growing customer experience enhancements, Alcami RightNow grants existing clients, prospective partners, and information seekers immediate answers to questions and quick access to materials, resources, and relevant content by directly communicating with live Alcami experts.

Alcami President & Chief Executive Officer Dr. Stephan Kutzer recently took part in an interview for Manufacturing Chemist titled "Fuelling Pharma's Innovation Engines." 

According to Stephan, small and mid-size pharma and biologics companies are the innovation engines of the industry. “Each year, the number of new INDs and NDAs increases and we anticipate this trajectory to continue. We see more than 5000 clinical introductions on an annual basis. Cancer treatments are a particular area of focus for many of our clients and we expect our pipeline for these therapies to grow within the next 5 years. Our target accessible market is around $8 billion.”

KR: How does Alcami plan to grow with the industry?

SK: We have strategically invested in capability extensions and operational excellence initiatives to better meet industry demand. At our Germantown (Wisconsin, USA) Center of Excellence for API development, scale-up and commercialisation, we have supplemented our existing pipeline with HPAPI suites and controlled substance capabilities.

Name: Bee Fread
Alcami Site: Durham, NC

How long have you been with Alcami?
I have been with Alcami since December 2015.

What is your role? 
I am a supervisor of the biotech team at Alcami’s Durham, North Carolina site.

What is the most rewarding part of your job?
The most rewarding part of my job is working with my team and collaborating with colleagues in other departments to overcome challenges and work together to meet client commitments.

Alcami and the University of North Carolina Wilmington (UNCW) have partnered on an academic program that connects education and work experiences for students pursuing scientific careers, especially in pharmaceutical sciences. This edition of the Beyond the Bench series will highlight the laboratory-based course taught at UNCW’s state-of-the-art marine biotechnology center (MARBIONC), “Current Good Pharmaceutical Quality Control Laboratory Practice,” focused on the application of Current Good Manufacturing Practices (cGMPs) in a drug development and testing laboratory.

In 2016, leaders from Alcami and UNCW met to discuss potential opportunities to work together on biopharmaceutical projects. Many of Alcami’s Wilmington employees are UNCW graduates, and Alcami has a long history working with the university on employee education programs and pharmaceutical projects. Steve Fontana, JD, from UNCW’s Office of Intellectual Property and Commercialization; UNCW Chancellor Dr. Jose V. Sartarelli, and Alcami President and Chief Executive Officer (CEO) Dr. Stephan Kutzer initiated conversations that resulted in the development of the present partnership.

Throughout the development lifecycle of oral solid dosage (OSD) drug products, possible challenges must be immediately addressed to keep timelines on track. In early-stage OSD formulation development, complex solubility issues, difficult-to-formulate products, poorly controlled pharmacokinetics, polymorphism and stability, and limited amounts of the active pharmaceutical ingredient (API) all can lead to delays in development. During late-stage development, product manufacturability challenges can occur with processing and packaging as higher scale manufacturing can significantly impact the physicochemical characteristics of a product.

Alcami will be attending DCAT Week 2019, to be held March 18 - 21 in New York, NY.

Name: Marilyn Heidbrink
Alcami Site: St. Louis, MO

How long have you been with Alcami?
I joined the Alcami team in August 2016.

What is your role? 
My title is Technical Specialist. I interact with sales and clients to understand the scope of the client’s project in order to draft protocols and reports for client projects. I also execute the validation and transfer activities. Additionally, I assist project managers and analysts with their technical questions. 

What is the most rewarding part of your job?
It is very rewarding when we execute analytical validations and issue reports which are then used to launch new products. It’s so inspiring to see a project from its beginning with validation to clinical use in patients.

Alcami recently contributed to a special feature in Drug Development and Delivery magazine titled "Outsourcing Analytical Testing: The Gateway to Drug Manufacturing."

Alcami: Customizing Programs to Meet Accelerated Product Timelines

Alcami is a CDMO that offers fully integrated, comprehensive analytical testing to support technologies for every stage of development. Its laboratory services platform is comprised of analytical testing and development services for small molecule and biologics drug products, as well as specialized offerings such as elemental impurities, abuse deterrence, and extractables and leachables. In addition, formulations development scientists address challenges related to new chemical entities.

Alcami recently authored an article featured in Drug Development & Delivery titled "A Practical Approach to Extractables & Leachables." 

INTRODUCTION

The study of extractables and leachables (E&L) has been evolving for many years. As pharmaceutical manufacturers, packaging vendors, and regulatory agencies gain more knowledge of extractable compounds, the scope of E&L guidelines grows with it. Many of the case studies that initiated interest in extractables and leachables are based on primary packaging. In some cases, the secondary or tertiary packaging were identified as sources of leachables. As a result, the primary emphasis of extractables screens has been on the packaging systems. The approach to these screens is well established. The first iterations of regulatory guidance addressed the common packaging materials in the United States Pharmacopeia (USP) chapter <661>, which relied heavily on physiochemical testing to characterize the material of construction but did not directly address extractables testing of the final packaging materials in detail. With advancements in the manufacture of plastics and increasing variety of base polymers used for packaging systems, it became evident that more specific guidelines are needed.